To study the effects of two drugs, R-TPR-017 and Mabthera® (Ristova®) in cancer patients (Non-Hodgkin’s Lymphoma)

Phase 3

Completed

• Conditions: Patients with Non-Hodgkin’s Lymphoma

• Registration Number: CTRI/2011/12/002232
• Lead Sponsor: Reliance Life sciences Pvt Ltd

Brief Summary

This was a prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate the efficacy and safety of R-TPR-017/ Mabthera® (Ristova®) in patients with Non Hodgkin’s Lymphoma. The analysis of primary efficacy end point i.e.ORR at week 24 shows comparable response for both R-TPR-017 and MabThera®(Ristova®) arm (87.87% Vs. 86.86%). The proportions of subjectsshowing ORR in each arm were compared for statistical significance and thedifference was found to be non-significant.The safety and efficacy of the R-TPR-017 was comparable to Mabthera® (Ristova®) in  terms of ORR, progression free survival and overall survival.  The adverse events for both treatment groups wereconsistent with the known safety profile of R-CHOP. No new safety concerns wereidentified with respect AE in either arm in this study.  Thus R-TPR-017 was found to be comparable in terms of safety and efficacy in patients with newly diagnosed diffuse large-B-cell lymphoma or follicular lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-21
• Study Completion: 2019-12-02
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Previously untreated patients 2.
• Histologically confirmed, newly diagnosed follicular B cell Non-Hodgkins lymphoma or diffuse large B cell Non-Hodgkins lymphoma 3.
• CD20 positive by immunohistochemistry 4.
• Patients with at least one target lesion (lymph node with short axis of less than or equal to 15 mm by CT scan with contrast) 5.
• ECOG performance status 0 to 2 6.
• Life expectancy more than six months 7.
• Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirements 8.
• Consent from Legally Acceptable Representative (LAR), if subject is not in a condition to give consent.
• However, when the subject is stable and is able to give consent, the consent would be obtained on a separate ICF to confirm his/her willingness to continue participation in the study.

Exclusion Criteria

• Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis) 2.
• Patients with prior or concomitant malignancy 3.
• Patients with abnormal laboratory parameters like: •Serum creatinine 2.0 times of upper normal limit •AST or ALT 2.5 times of upper normal limit •Alkaline phosphatase ≥1.5 times of upper normal limit •Platelet count 100,000/ZL.
• •Hemoglobin 8.0 g/dL.
• •Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
• History of prior chemotherapy, stem cell transplant and radiotherapy 5.
• History of high dose, systemic, steroid therapy within 6 weeks 6.
• Previous use of non-human monoclonal antibody therapy and or known hypersensitive to murine proteins 7.
• Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. Active systemic infection) 8.
• Severe cardiovascular disease within 12 months including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias or uncontrollable hypertension 9.
• Pregnant or lactating females or women of child-bearing potential, unwilling or unable to use proper contraceptive precautions during the study 10.
• Subjects with HIV, HBsAg, HCV test positive 11.
• Subject participation in another clinical trial 30 days prior to administration of IP 12.
• Any other condition which the Investigator feels would pose a significant hazard to subject if IP is administered.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria	at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with Objective Response Rate {Complete Response and Partial Response} assessed by RECIST 1.1 criteria	At 10 weeks, 24 weeks, 1year, 1.5 year and 2 year

Trial Locations

Locations (26)

Action Cancer Hospital, New Delhi; 🇮🇳 Delhi, DELHI, India

Asirvatham Speciality Hospital, Madurai; 🇮🇳 Madurai, TAMIL NADU, India

Axon Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Baraskar Hospital & Research Centre, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Bharat Cancer Hospital and Research Institute; 🇮🇳 Surat, GUJARAT, India

Bhatia Hospital Medical Research Society; 🇮🇳 Mumbai, MAHARASHTRA, India

Deenanath Mangeshkar Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Delhi State Cancer Institute; 🇮🇳 East, DELHI, India

Government Medical College; 🇮🇳 Nagpur, MAHARASHTRA, India

Gujarat Cancer & Research Institute, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

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Action Cancer Hospital, New Delhi

🇮🇳Delhi, DELHI, India

Dr J B Sharma

Principal investigator

9811167505

dr_sharmajb@rediffmail.com